VivaChek Blood Glucose and B-Ketone Monitoring System— 510(k) K192957

Substantially Equivalent

Vivachek Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K192957 for VivaChek Blood Glucose and B-Ketone Monitoring System, Substantially Equivalent on 2020-06-05. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd..

Clearance details

Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
Product code: Code JIN
Advisory panel: Clinical Chemistry
Date received: 2019-10-21
Decision date: 2020-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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